POLYETHYLENE GLYCOL, UNSPECIFIED

FDA Drug Profile — Polyethylene Glycol 3350 Powder for Solution

POLYETHYLENE GLYCOL, UNSPECIFIED is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Polyethylene Glycol 3350 Powder for Solution. Available dosage form: powder, for solution.

Drug Details

Generic Name
POLYETHYLENE GLYCOL, UNSPECIFIED
Brand Names
Polyethylene Glycol 3350 Powder for Solution
Application Number
ANDA203928
Sponsor
VALLEY MEDICAL PRODUCTS, LLC
NDC Codes
1
Dosage Forms
POWDER, FOR SOLUTION
Routes
TOPICAL
Active Ingredients
POLYETHYLENE GLYCOL 3350

Indications and Usage

Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Warnings

Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have • nausea, vomiting or abdominal pain • a sudden change in bowel habits that lasts over 2 weeks • irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.